288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-004675-13-HR (EUCTR) | 28/11/2020 | 02/12/2020 | Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. | CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATEDURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) | Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Wilate 500 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: Wilate 1000 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 3 | United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||
| 2 | EUCTR2019-002023-15-IT (EUCTR) | 17/04/2020 | 17/06/2021 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients = or >12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)] Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)] Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR -XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)] Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - Product Name: Recombinant coagulation FVIII Fc –von Willebrand factor – XTEN fusion protein Product Code: [BIVV001 (rFVIIIFc-VWF-XTEN)] Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTO | BIOVERATIV THERAPEUTICS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2019-002023-15-DE (EUCTR) | 25/02/2020 | 09/10/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa | Bioverativ Therapeutics Inc. (a Sanofi company) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2019-002023-15-FR (EUCTR) | 06/02/2020 | 04/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) | Bioverativ Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 5 | EUCTR2019-002023-15-ES (EUCTR) | 28/01/2020 | 02/12/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients >=12 Years of Age With Severe Hemophilia A - XTEND-1 | Severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein | Bioverativ Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 6 | EUCTR2019-002023-15-BG (EUCTR) | 22/01/2020 | 06/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa | Bioverativ Therapeutics Inc. (a Sanofi company) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 7 | EUCTR2019-002023-15-HU (EUCTR) | 21/01/2020 | 20/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) | Bioverativ Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 8 | EUCTR2019-002023-15-GB (EUCTR) | 06/01/2020 | 10/10/2019 | NA Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1). | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | Severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) | Bioverativ Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan | ||
| 9 | EUCTR2019-002023-15-GR (EUCTR) | 27/12/2019 | 13/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | Severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa | Bioverativ Therapeutics Inc. (a Sanofi company) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | ||
| 10 | NCT04161495 (ClinicalTrials.gov) | December 4, 2019 | 5/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A | A Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A | Factor VIII Deficiency | Drug: efanesoctocog alfa (BIVV001) | Bioverativ, a Sanofi company | NULL | Completed | 12 Years | N/A | All | 159 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Spain;Taiwan;United Kingdom |
| 11 | EUCTR2018-004675-13-HU (EUCTR) | 04/06/2019 | 05/04/2019 | Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. | CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) | Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Wilate 500 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: Wilate 1000 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Czech Republic;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | ||
| 12 | EUCTR2018-001631-46-NL (EUCTR) | 14/02/2019 | 13/02/2019 | Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease | Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To WiN | Von Willebrand disease MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Minrin INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Haemate P INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII Trade Name: Wilate INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Wilfactin INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Veyvondi INN or Proposed INN: VON WILLEBRAND FACTOR Other descriptive name: VON WILLEBRAND FACTOR | Erasmus University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 13 | EUCTR2013-003305-25-GR (EUCTR) | 02/02/2016 | 17/12/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 14 | EUCTR2013-003305-25-DE (EUCTR) | 19/11/2015 | 02/06/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 19.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 15 | EUCTR2013-003305-25-AT (EUCTR) | 22/09/2015 | 25/06/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 16 | EUCTR2013-003305-25-PT (EUCTR) | 11/09/2015 | 19/08/2015 | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Portugal;Ireland;United Kingdom | |||
| 17 | EUCTR2013-003305-25-IE (EUCTR) | 03/09/2015 | 09/07/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | ||
| 18 | EUCTR2013-003305-25-GB (EUCTR) | 07/07/2015 | 05/05/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 18.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany;United Kingdom;Greece;Poland;Ireland;Austria | ||
| 19 | EUCTR2006-001383-23-DE (EUCTR) | 19/09/2013 | 21/05/2013 | Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings | Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings - PRO.WILL. | Patients with severe, inherited Von Willebrand’s disease and frequent bleedings MedDRA version: 16.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: FANHDI*INF FL250UI+SIR SOLV+S Product Name: FANHDI 25 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S Product Name: FANHDI 50 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S Product Name: FANHDI 100 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 20 | EUCTR2011-000181-34-IT (EUCTR) | 20/05/2012 | 07/08/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Satefy of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies - NA | Acquired Haemophilia A MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 Other descriptive name: recombinant porcine coagulation factor VIII (B domain deleted) | INSPIRATION BIOPHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India | |||
| 21 | EUCTR2006-001383-23-GB (EUCTR) | 19/04/2012 | 13/01/2010 | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Severe, inherited von Willebrand disease (VWD) and frequent bleedings MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Alphanate Product Name: Alphanate 1000 I.U. Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Alphanate Product Name: Alphanate 1500 I.U. Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | Prof Flora Peyvandi, MD | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Germany;Italy;United Kingdom | ||
| 22 | EUCTR2010-021162-30-BG (EUCTR) | 20/12/2011 | 07/12/2011 | This study in an open label study that is conducted in many centers around the world to investigate whether Wilate is safe and works in patients that need surgery and have von Willebrand disease. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate®) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures. | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: WILATE 500 I.U. Product Code: WILATE 500 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) Product Name: WILATE 1000 I.U. Product Code: WILATE 1000 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Russian Federation;Bulgaria;Italy;India | ||
| 23 | EUCTR2010-023666-46-PL (EUCTR) | 13/12/2011 | 20/12/2011 | A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY | EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES | HAEMOPHILIA A MedDRA version: 14.1;Level: LLT;Classification code 10018938;Term: Haemophilia A (Factor VIII);System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: FACTANE 200 IU/ml Product Code: F8VR Other descriptive name: HUMAN COAGULATION FACTOR VIII | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: no Male: yes | Poland | ||||
| 24 | EUCTR2009-017301-11-DE (EUCTR) | 17/11/2011 | 13/07/2011 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 25 | EUCTR2010-021162-30-IT (EUCTR) | 20/09/2011 | 07/03/2012 | Clinical trial to test if the study drug is safe and if it works well in severe Type 3 von Willebrand patients that need to have a major surgery. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Disease (VWD) Who Undergo Major Surgical Procedures. - WIL-24 | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Wilate 500 I.U. Product Code: Wilate 500 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) Product Name: Wilate 1000 I.U. Product Code: Wilate 1000 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Bulgaria;Russian Federation;Italy;India | ||
| 26 | EUCTR2011-000181-34-GB (EUCTR) | 29/06/2011 | 23/06/2011 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Haemophilia A MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 INN or Proposed INN: obyoctocog alfa Other descriptive name: recombinant porcine coagulation factor VIII (B-domain deleted) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 27 | EUCTR2009-017301-11-PL (EUCTR) | 29/09/2010 | 18/08/2010 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 16.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Bulgaria;Russian Federation;Germany | |||
| 28 | EUCTR2009-017301-11-BG (EUCTR) | 20/09/2010 | 25/06/2010 | This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study). | An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 | Von Willebrand's Disease MedDRA version: 14.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Poland;Ukraine;Russian Federation;Bulgaria;Germany | |||
| 29 | EUCTR2009-017753-34-DE (EUCTR) | 09/07/2010 | 15/01/2010 | This clinical study investigates the effectiveness and safety of Biostate in children with von Willebrand’s disease (VWD), a blood clotting disorder. A two day investigation of the pharmacokinetics on 0,5, 4 8 12 24 and 48 h after administration (metabolism of Biostate by the child’s body) is a part of the investigation. | A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease. | Von Willebrand Disease MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Germany | ||
| 30 | EUCTR2008-004922-18-BG (EUCTR) | 16/04/2009 | 13/04/2009 | An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease. | An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease. | Von Willebrand Disease MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease MedDRA version: 9.1;Level: PT;Term: Von Willebrand's disease | Product Name: Biostate® Other descriptive name: von Willebrand Factor Other descriptive name: Human Coagulation Factor VIII | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Bulgaria | |||
| 31 | EUCTR2008-001910-25-SK (EUCTR) | 17/07/2008 | 13/05/2008 | Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study | Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study | Inherited von Willebrand Disease (VWD) type 3 MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: WILATE® 450 INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination Trade Name: Haemate® P 250 INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Slovakia | ||
| 32 | EUCTR2005-001426-84-FR (EUCTR) | 14/12/2006 | 23/10/2006 | Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14 | Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14 | Wllebrand disease MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: WILATE 450 INN or Proposed INN: human coagulation factor VIII INN or Proposed INN: Factor von Willebrand Trade Name: WILATE 900 INN or Proposed INN: human coagulation factor VIII INN or Proposed INN: Factor von Willebrand | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | France;Czech Republic;Germany | ||
| 33 | EUCTR2006-001383-23-IT (EUCTR) | 30/06/2006 | 28/11/2006 | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILL | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WILL | patients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: ALPHANATE*INF 1F 1500UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL 250UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 500UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 1000UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI 250UI*1F 250UI+F 10ML INN or Proposed INN: Coagulation factor VIII | FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 34 | EUCTR2005-004496-38-DK (EUCTR) | 22/06/2006 | 09/05/2006 | Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy. | Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy. | von Willebrand disease (VWD) is an inherited bleeding disorder, characterised mainly by mucosal bleedings, which may be life-threatening, and joint bleeds in severe VWD cases. VWD is caused by a lack of von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Treatment of VWD aims at normalizing the VWF activity in plasma, which can be achieved by stimulating the endogenous release of VWF with desmopressin (DDAVP, 1-desamino-8-D arginine vasopressin) or by infusion of a VWF concentrate. | Trade Name: Octostim Product Name: Octostim Product Code: DDAVP (Desmopressin) Trade Name: Octostim Product Name: Octostim Product Code: DDAVP (Desmopressin) | Rigshospitalet, Copenhagen | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Denmark | ||
| 35 | NCT02250508 (ClinicalTrials.gov) | December 2004 | 2/9/2014 | A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease. | A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease. | vonWillebrand's Disease | Biological: Optivate® (Human Coagulation Factor VIII);Biological: Haemate P® (Human Coagulation Factor VIII) | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | Phase 2 | Israel | |
| 36 | NCT02246881 (ClinicalTrials.gov) | October 2001 | 2/9/2014 | A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A. | An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients. | Von Willebrand Disease | Biological: Optivate® (Human Coagulation Factor VIII) | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | Phase 3 | Poland;United Kingdom | |
| 37 | NCT00168090 (ClinicalTrials.gov) | October 2001 | 12/9/2005 | Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) | Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease. | Von Willebrand Disease;Blood Coagulation Disorders;Blood Platelet Disorders;Hematologic Disease | Drug: Blood coagulation Factor VIII and vWF, human | CSL Behring | NULL | Completed | N/A | N/A | Both | 30 | Phase 4 | United States |
| 38 | EUCTR2018-004675-13-BG (EUCTR) | 27/02/2019 | Study to investigate the study drug (WILATE) in patients with Von Willebrand Disease. | CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATEDURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) | Von Willebrand disease, type 3, type 2 (except 2N), or severe type 1 MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Wilate 500 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: Wilate 1000 Product Name: Wilate INN or Proposed INN: Human Coagulation Factor VIII, Von Willebrand Factor Complex Other descriptive name: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | United States;Belarus;Hungary;Ukraine;Lebanon;Croatia;Russian Federation;Bulgaria | |||
| 39 | EUCTR2014-005401-20-Outside-EU/EEA (EUCTR) | 30/01/2015 | An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD) | An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD) | Von Willebrand's disease (VWD) MedDRA version: 17.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Voncento, Biostate® Product Name: Human coagulation Factor VIII / von Willebrand Factor | CSL Limited | NULL | NA | Female: yes Male: yes | 23 | Australia | ||||
| 40 | EUCTR2019-002023-15-NL (EUCTR) | 25/11/2019 | A Phase 3, Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, BIVV001, in Patients With Severe Hemophilia A (XTEND-1) | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa | Bioverativ Therapeutics Inc. (a Sanofi company) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands;Japan;Korea, Republic of | |||
| 41 | EUCTR2013-003305-25-PL (EUCTR) | 10/11/2015 | Study of Voncento® in Subjects with Von Willebrand Disease | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease | Von Willebrand Disease MedDRA version: 20.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Voncento Product Name: Voncento INN or Proposed INN: Human Coagulation Factor VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: Human Von Willebrand Factor Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Greece;Poland;Ireland;Austria;Germany;United Kingdom | |||
| 42 | EUCTR2019-002023-15-BE (EUCTR) | 08/11/2019 | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein(rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients =12 Years of Age With Severe Hemophilia A - XTEND-1 | severe hemophilia A MedDRA version: 20.0;Level: PT;Classification code 10016080;Term: Factor VIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa Other descriptive name: RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN Product Name: Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein Product Code: BIVV001 (rFVIIIFc-VWF-XTEN) INN or Proposed INN: Efanesoctocog alfa | Bioverativ Therapeutics Inc. (a Sanofi company) | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | United States;Taiwan;Greece;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | |||
| 43 | EUCTR2009-017753-34-BG (EUCTR) | 13/10/2011 | This clinical study investigates the effectiveness and safety of Biostate in children with von Willebrand's disease (VWD), a blood clotting disorder. A two day investigation of the pharmacokinetics (metabolism of Biostate by the child's body) is a part of the investigation – 0.5, 4, 8, 12, 24 and 48h after administration. | A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease. | Von Willebrand Disease MedDRA version: 14.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Product Name: Biostate Other descriptive name: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | Belarus;European Union;Mexico;Guatemala;Ukraine;Lebanon;Georgia;Bulgaria;Germany | |||
| 44 | EUCTR2006-000663-28-PL (EUCTR) | 05/11/2007 | An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate | An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate | von Willebrands Disease MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: Optivate Product Code: N/A INN or Proposed INN: Human coagulation factor VIII associated with von Willebrand factor (VWF) | Bio Products Laboratory | NULL | NA | Female: yes Male: yes | 26 | Phase 3 | Poland;United Kingdom | |||
| 45 | EUCTR2006-000664-85-PL (EUCTR) | 24/10/2007 | An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery | An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery | von Willebrand disease MedDRA version: 9.1;Level: LLT;Classification code 10047715;Term: Von Willebrand's disease | Product Code: N/A INN or Proposed INN: Human coagulation factor VIII associated with Von Willebrand factor (VWF) | Bio Products Laboratory | NULL | NA | Female: yes Male: yes | 25 | Phase 3 | Poland;United Kingdom |